EnSite Velocity Cardiac Mapping System v5.2
FDA 510(k) K172396 · St Jude Medical
510(k) numberK172396
Submission
- Device name
- EnSite Velocity Cardiac Mapping System v5.2
- Applicant
- St Jude Medical
St. Paul, MN, US - Received
- August 8, 2017
- Decision date
- April 23, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
Other 510(k)s with product code DQK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262005 | Affera Integrated Mapping SystemDQK · Special | Medtronic, Inc. | 08/21/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | Boston Scientific | 08/21/2026SE |
| K253576 | CorVista System® with PCWP Add-OnDQK · Traditional | Analytics For Life, Inc. | 07/26/2026SE |
| K262006 | EnSite X EP SystemDQK · Special | Abbott Medical | 07/15/2026SE |
| K252978 | ScioCardio ECG Analysis PlatformDQK · Traditional | Synergen Technology Labs, LLC | 07/09/2026SE |
| K253463 | ILR ECG Analyzer (IM007)DQK · Traditional | Implicity, Inc. | 07/02/2026SE |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01)DQK · Special | Imricor Medical Systems, Inc. | 06/30/2026SE |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO)DQK · Traditional | Micropace Pty, Ltd. | 06/12/2026SE |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…DQK · Special | Centerline Biomedical | 06/10/2026SE |
| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | iRhythm Technologies, Inc. | 05/29/2026SE |
More from iRhythm Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K181382 | GuardianTM Burr Hole Cover SystemGXR · Abbreviated | 07/20/2018SE |
| K172393 | Advisor HD Grid Mapping Catheter, Sensor EnabledMTD · Traditional | 04/23/2018SE |
| K173232 | myMerlin(TM) Mobile Application Model APP1001MXC · Special | 11/02/2017SE |
| K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) SystemMXC · Traditional | 09/29/2017SE |
| K162643 | MediGuide Technology SystemDQK · Traditional | 12/13/2016SE |
| K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12…DRF · Traditional | 12/13/2016SE |
| K160218 | AutoMark ModuleDQK · Traditional | 12/13/2016SE |
| K160210 | EnSite Precision Cardiac Mapping System v2.0DQK · Traditional | 12/13/2016SE |
| K161873 | Pacel Flow Directed Pacing CatheterLDF · Traditional | 11/22/2016SE |
| K160187 | Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0DQK · Traditional | 10/21/2016SE |
Questions and answers
When was EnSite Velocity Cardiac Mapping System v5.2 cleared by the FDA?
EnSite Velocity Cardiac Mapping System v5.2 (K172396) received a 510(k) decision of Substantially Equivalent on April 23, 2018, 258 days after the submission was received.
What is the product code of K172396?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.